Dr. Dennis Jenke is a Baxter Distinguished Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. In this role, he works with a team of analytical chemistry professionals whose primary responsibility includes the development, validation and application of diverse analytical strategies and methods for the discovery, identification and quantification of trace constituents in pharmaceutically relevant solutions and samples.
Philippe Verlinde PhD
Nelson Labs Europe
Philippe Verlinde, Ph.D. Ir. Senior Scientist - Study Director Dr. Verlinde received his Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2009. He worked as a postdoctoral fellow at the University of Leuven (Bioscience Engineering), conducting research in the field of food technology and analytics.
From 2010 to 2013 he joined the Institute for Reference Materials and Measurements (IRMM) of the European Commission’s Joint Research Centre as a scientific support officer and was involved in several research projects in the field of method standardization (CEN, ISO), proficiency testing and regulatory aspects of environmental pollutants and food safety. Due to his background he has gained a strong expertise in analytical chemistry, especially in the field of structural elucidation techniques (NMR, MS), method development and validation, trace analysis by chromatography (GC & LC) hyphenated to mass spectrometry (small molecules). In 2013 he joined Toxikon Europe as an analytical expert and study director at the Pharma Department, focusing on impurity identification projects.
Since 2016 he is acting as a senior scientist in the R&D team at Nelson Labs Europe and is involved in automation projects and the development of state-of-the art analytical services related to extractables and leachables studies for the pharmaceutical and medical device industries.
Mac Taylor D.V.M., DABT
SafeBridge Regulatory Life Sciences Group
Mac is a Managing Toxicologist for SafeBridge Regulatory Life Sciences Group and has over 16 years’ experience in pharmacology and toxicology as a researcher, study monitor, and consultant. He has been involved in the toxicological assessment extractable and leachable studies since 2010. Mac is certified by the American Board of Toxicology and holds a D.V.M. from the North Carolina State University, College of Veterinary Medicine
Dr. Cheryl Stults
C&M Technical Consulting
Dr. Stults is Principal at C & M Technical Consulting, LLC, working with various local and global companies to advance the development of parenteral and inhalation products. Her primary area of focus is on device and packaging materials analysis and characterization for purposes of selection, qualification and control. She holds a Ph.D. in Analytical Chemistry from Michigan State University and a Masters in Management from Aquinas College. Prior positions include: Senior Fellow at Novartis Pharmaceuticals Corporation, Assistant Research Professor at San Francisco State University and Quality Associate at a Johnson & Johnson owned company. She was co-editor of the Leachables and Extractables Handbook (Wiley 2012) and has been a member of the Board of Directors for two consortia: Extractables and Leachables Safety Information Exchange (ELSIE) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). She has been actively involved in the ELSIE Pilot Protocol Study and database development. She previously led IPAC-RS working groups to develop Materials Baseline Requirements for OINDP, a Leachables and Extractables Development Paradigm and a Chemical Risk Evaluation tool and has continued involvement as an IPAC-RS Science Advisor participating in global outreach and materials related initiatives. Dr. Stults is currently a USP Packaging and Distribution Expert Committee member contributing to development and revision of materials-related chapters.
Principal Scientist Extractables and Leachablesat
Carsten Worsøe is a research scientist in an analytical development department at Novo Nordisk. In over 18 years at Novo Nordisk, his main responsibility has been to develop analytical methods for L&E test procedures of new packaging/container closure systems under development. Within Novo Nordisk Carsten has been one of the main actors to bring relevant people in packaging materials, toxicology, formulation, regulatory and analytical together to perform risk assessments and strategies for L&E testing in development projects.
James M. Vergis, Ph.D.
Director Science, Research, & Innovationat
Jamie is a Director in the law firm of Faegre Drinker Biddle and Reath, LLP providing scientific and strategic consulting services to individual clients and various Pharmaceutical and Biotechnology consortia. He is particularly adept at helping clients streamline the development of new technology and data-sharing processes. As a scientist whose work has touched on various fields of study, Jamie is passionate about helping his clients cultivate new scientific knowledge and drive public policy changes that enhance the drug-development process. Within ELSIE, Jamie is one of the members of the ELSIE Secretariat. He is primarily responsible for the Knowledge Base project and data sharing initiatives currently underway in the consortium. Jamie has a BSc in biochemistry with a minor in computer science from SUNY Geneseo and a PhD in molecular biophysics and biochemistry from Yale University.
Risk Science Consortium, LLC & US FDA (Retired)
Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.
Dujuan Lu, Ph.D.
SGS Health Sciences
Dr. Dujuan Lu serves as the manager for the extractables and leachables (E&L) team at the SGS Fairfield New Jersey facility as well as the global leader amongst the three centers of excellence for E&L testing. Before joining SGS, she worked at Fresenius Kabi as a research scientist, leading E&L projects to support transfusion and infusion medical device and parenteral products. She has extensive CRO and pharmaceutical/medical device industry experience with more than 500 E&L projects on a broad range of packaging systems, including process materials, pharmaceutical finished packaging, and medical devices. As a subject matter expert in the E&L field, she is frequently presenting at various conferences as invited speakers and technical session chairs. She was named one of the top 60 most influential people working in the pharmaceutical industry in the Medicine Maker’s 2020 power list.
Dr. Lu obtained her PhD in analytical chemistry from the University of Pittsburgh and BS in chemistry from Nanjing University. She has authored more than 15 high-impart journal publications with more than 300 citations. She is serving as an expert reviewer for more than 10 prestigious journals in the field of analytical chemistry and pharmaceutical science.
Dr. Martyn Chilton
Martyn Chilton is a Principal Scientist at Lhasa Limited, where he leads the research efforts around creating, improving, and applying in silico models to predict skin sensitisation and related toxicity endpoints. He is particularly interested in how such models can be applied to make real world safety and risk decisions. Since joining Lhasa Limited in 2015 he has been fortunate to be involved in several interesting projects and collaborations in this field, including membership of the working group which helped create OECD guideline 497 on defined approaches for skin sensitisation.
Senior Director, Analytical Chemistry and Regulatory Toxicologyat
WuXi AppTec Medical Device Testing
With over 25 years' experience, Ms. Schaible is responsible for oversight and direction of WuXi AppTec's Analytical Chemistry department in St Paul, Minnesota. The analytical staff she manages is responsible for providing custom chemistry testing services including extractables/leachables, materials characterization and target analysis testing, method development, method validation as well as standardized testing including compendial testing. Ms. Schaible received her Bachelors of Science in Chemistry from Winona State University, and has experience working in the pharmaceutical, medical device, environmental and R&D industries, including over 15 years of analytical experience in GLP, GMP, FDA and ISO regulated laboratories. Ms. Schaible provides technical guidance and testing program design, and is an international and U.S. delegate for TC 194, the technical committee for ISO 10993.
Dr. Roberto Menzel graduated from FSU University Jena and holds a Ph.D. in Chemistry. He started his career as an assistant editor in the natural science book section at Wiley followed by a position as group leader for the organic trace analysis in the environmental analytical division at Eurofins Scientific. In 2015, he joined Sartorius Stedim Biotech where he is heading the internal analytical laboratory and Extractables group. The main working areas are material and product qualification studies for single-use (SU) systems and components for the biopharmaceutical industry. He authored several articles on the characterization of plastics and SU devices regarding extractable compounds.
Sam started his career as an R&D chemist formulating coating formulations with the same additives that he now spends his time detecting and identifying in the extractables and leachables industry. Sam has a vast expertise in overcoming the analytical challenges that can present themselves when performing E&L data analysis. He manages an exceptional team of liquid chromatographers at VR Analytical, an E&L industry leader.
Joel M. Cohen, Sc.D., DABT
Senior Toxicologist at
Dr. Cohen is a board certified toxicologist and Principal at the consulting firm Gradient. With expertise in computational toxicology and human health risk assessment, Dr. Cohen's primary responsibilities include non-clinical safety assessments of medical device and pharmaceutical components, regulatory compliance assessments, cancer risk assessment, and physiologically based pharmacokinetic modeling. Before joining Gradient, Dr. Cohen earned his doctoral degree at the Harvard School of Public Health, applying in vitro cellular models to study the fate, transport and toxicity of nanoparticles in the lung. He has authored over twenty high impact peer-reviewed articles and one patent, and presented his work to academic and general audiences.
Candice Johnson, Ph.D.
Senior Research Scientistat
Candice Johnson, Ph.D. is a Senior Research Scientist at Instem. She is interested in the application of in silico tools for the analysis of various toxicological endpoints such as skin sensitization, irritation and corrosion as well as endocrine disruption. Her publications include case studies on the application of a framework which allows for transparent and reproducible in silico assessments with an assignment of reliability and confidence. An extension of this work is exploring how to more broadly apply in silico tools towards non-traditional applications.
Intertek Pharmaceutical Services
Gyorgy Vas has over 25 years of experience in scientific research, pharmaceutical and medical device product development, and laboratory management. Over 15 years was spent in a cGMP environment, where that scientific expertise was applied to solve problems related to finished pharmaceutical products and medical devices. In his current position, he is advising regulatory filing strategy for multiple clients, and his group provides solutions for mitigate deficiency letters. He is serving as an internal scientific consultant to the laboratory operations, evaluating new analytical techniques, software products for extractables and leachables testing. As part of his current role he is involved to evaluate and implement non-routine analytical instrumentations and methods for cGMP use. He published more than 20 analytical papers, related to various activities, including sample preparation, trace level method validation, molecular imaging, structure elucidation, and E&L testing. Those scientific publications papers have been cited more than 3000 times over the years.
Senior Principal Scientistat
PPD’s cGMP lab, a part of Thermo Fisher Scientific.
Dr. Xiaochun Yu is a Senior Principal Scientist at PPD’s cGMP lab, a part of Thermo Fisher Scientific. Dr. Yu is a leading scientist on extractables/leachables studies. He also has extensive experience on analytical method development, validation, and structure identification.
Global Subject Matter Expert for GSK Vaccinesat
Marine LEPOUTRE currently holds the position of Global Subject Matter Expert in Extractable & Leachable at GSK Vaccines and is responsible for aligning all GSK Vaccines sites with current regulatory requirements. Before this position, in his role of process expert for Belgium site, she leads process validation as homogeneity, holding time, lifetime and lyophilisation. Marine is a Chemical Process Engineer with a master’s degree in Chemistry from CPE Lyon in France.
Dr. Karl Abele
Team leader HRAM Mass Spectrometry at
Solvias AG (Switzerland) Solvias LLC (Boston, USA)
Karl studied organic chemistry with a Ph.D in 1988 and has been using hyphenated GC/MS and LC/MS equipment since 1985. He worked for main 3 MS manufacturers as application chemist or product manager from 1990 – 2008, using quadruples, triple quadrupole and Q-ToFs. Since 2009, he is leading the Solvias E&L team in Switzerland, using multiple HRAM-LC/MS/MS systems (Q-Exactive Orbitrap) and GC/MS Triple quadrupoles. In 2021, his team has started using HRAM-GC/MS instead of quadrupoles – to further increase ID rates in E&L studies, ideally to 100%. Since 2023, Karl’s main interest is the integration of Solvias Swiss based E&L team with the US based team of Solvias LLC (former Chemic Laboratories, Boston, USA).